title: Lapatinib plus capecitabine for HER2-positive advanced breast cancer: a multicentre study of Anatolian Society of Medical Oncology (ASMO).
abstract: Lapatinib is the first dual tyrosine kinase inhibitor of human epidermal growth factor receptor type 2 (HER2/neu) and epidermal growth factor receptor (EGFR). The present study evaluated the efficacy and tolerability of the combination of lapatinib and capecitabine in patients with metastatic breast cancer (MBC) who progressed after therapy with trastuzumab, a taxane and/or anthracycline. A total of 203 patients with a median age of 48 years (range: 25-82 years) were evaluated retrospectively in 11 centres between September 2007 and May 2011. All the patients had HER2-positive MBC progressing after trastuzumab and chemotherapy including an anthracycline and/or taxane. All patients were treated with the combination of lapatinib (1250 mg/day, continuously) and capecitabine (2000 mg/m(2) on days 1 through 14 of a 21-day cycle). Data on demographics, clinical outcome, and toxicity were collected for descriptive analyses. The median follow-up was 10·7 months (range: 1-40 months). An overall response rate (ORR) of 33·4% was achieved including 7 complete responses (CR, 3·4%), 61 partial responses (PR, 30·0%), and 44 stable disease (37·9%). Clinical benefit rate of 71·3% was achieved. Median progression-free survival (PFS) was 7 months (95% CI: 6-10 months), with a median overall survival (OS) of 15 months (95% CI: 12-18 months). The most common side effects were hand-foot syndrome (46·8%), nausea (42·3%), fatigue (42·2%), anorexia (38·5%), diarrhea (31·5%), and rash (29·6%). Grade 3-4 toxicities were identified as hand foot syndrome (7·9%), diarrhea (6·9%), fatigue (5·9%), and rash (5·4%). There were no symptomatic cardiac events. Lapatinib and capecitabine combination therapy is effective and well tolerated in patients with MBC who had progressive disease after trastuzumab, taxane, and/or anthracycline therapy, as evidenced by this retrospective evaluation. Toxicity was mild to moderate with low grade 3-4 toxicity.
authors.forename: Bulent
authors.initials: B
authors.lastname: Cetin
authors.forename: Mustafa
authors.initials: M
authors.lastname: Benekli
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Turker
authors.forename: Lokman
authors.initials: L
authors.lastname: Koral
authors.forename: Arife
authors.initials: A
authors.lastname: Ulas
authors.forename: Faysal
authors.initials: F
authors.lastname: Dane
authors.forename: Berna
authors.initials: B
authors.lastname: Oksuzoglu
authors.forename: Mehmet Ali
authors.initials: MA
authors.lastname: Kaplan
authors.forename: Dogan
authors.initials: D
authors.lastname: Koca
authors.forename: Cem
authors.initials: C
authors.lastname: Boruban
authors.forename: Burcak
authors.initials: B
authors.lastname: Yilmaz
authors.forename: Alper
authors.initials: A
authors.lastname: Sevinc
authors.forename: Veli
authors.initials: V
authors.lastname: Berk
authors.forename: Dogan
authors.initials: D
authors.lastname: Uncu
authors.forename: Hakan
authors.initials: H
authors.lastname: Harputluoglu
authors.forename: Ugur
authors.initials: U
authors.lastname: Coskun
authors.forename: Suleyman
authors.initials: S
authors.lastname: Buyukberber
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D000069287:Capecitabine; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D000077341:Lapatinib; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000037:antagonists & inhibitors* / Q000378:metabolism; D012189:Retrospective Studies
chemical_list: D000069287:Capecitabine; D003841:Deoxycytidine; D005472:Fluorouracil; D000077341:Lapatinib; D011799:Quinazolines; D018719:Erb-b2 Receptor Tyrosine Kinases
keywords: Advanced breast cancer,; Capecitabine,; HER2; Lapatinib,